MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED SHORT APPLIER; CLIP, IMPLANTABLE

Model Number MSM20

Device Problems Failure to Advance (2524); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t94t2l.Investigation summary: the analysis results found that the msm20 device was returned with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, it was noted that the clips did not advance into the jaw.In addition, the feeder shoe was noted to be stuck in home position, not allowing the clip to advance into the jaws.The device was disassembled in order to evaluate the condition of the internal components and the feeder spring was noted to be in opposite position.Eight clips were found inside clip track.The damage to the device has been correlated to the manufacturing process.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformance were identified.

Event Description

It was reported that during an unknown procedure, the clips were not engaging.The yellow 'pusher' was not moving clips to end as required/ expected.Originally, the device did not feed the clips.The clips would move if applier was turned upside down.However, then clips misfired.In some instances, they would not fire at all, in others they were malformed and would not clip properly.The device was not fired over another clip or hard structure.Discontinued use of this affected item and another product was opened; thus no delay to patient's surgery.The affected product did not cause harm to patient.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10512005
• MDR Text Key: 209342736
• Report Number: 3005075853-2020-04550
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002505
• UDI-Public: 10705036002505
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSM20
• Device Catalogue Number: MSM20
• Device Lot Number: T4100J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1